(87 days)
Not Found
No
The summary describes automated data interpretation and image processing but does not mention AI, ML, or related terms. The performance studies focus on equivalence to a predicate device using standard clinical and analytical methods, not on validating an AI/ML algorithm.
No.
The document states that the device is an "automated in vitro diagnostic (IVD) device" designed to detect nucleic acid targets in clinical specimens and provide test reports. This indicates a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels." It also mentions its purpose to "detect multiple nucleic acid targets contained in clinical specimens," which is a diagnostic function.
No
The device description explicitly states that the FilmArray 2.0 is an "automated in vitro diagnostic (IVD) device" that includes "one to eight instruments connected to a computer running FilmArray 2.0 software." It also details the functions of the instrument hardware, such as moving liquids, heating/cooling, and capturing fluorescence images. While software is a component, it is part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the FilmArray 2.0 is an "automated in vitro diagnostic (IVD) device".
N/A
Intended Use / Indications for Use
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The software automatically determines the results and provides a test report.
The FilmArray 2.0 is composed of one to eight instruments connected to a computer running FilmArray 2.0 software, which controls the function of each instrument and collects, and stores data generated by each instrument.
Product codes (comma separated list FDA assigned to the subject device)
NSU
Device Description
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed to work with specific FilmArray reagent panels to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with a reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray 2.0 software automatically determines the results and provides a test report.
The FilmArray 2.0 permits up to eight instruments to connect to one computer. This configuration reduces the space requirements for the system and offers centralized data management. Accessories for the FilmArray 2.0 include a computer stand and printer, a barcode scanner, an external Ethernet switch that allows several instruments to connect to a single computer, and an optional modular rack system to stack two instruments.
The main functions of the FilmArray 2.0 are as follows:
- Moving liquids within the pouch and delivering rehydrated reagents in a specified . sequence to drive the nucleic acid purification and PCR amplification reactions.
- . Heating and cooling to drive the PCR reactions and DNA melting.
- . Capturing and processing of fluorescence images for analysis by the software.
- . Automated data interpretation and test report generation.
Mentions image processing
Capturing and processing of fluorescence images for analysis by the software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the FilmArray 2.0 was evaluated using three FDA cleared FilmArray Panels (Respiratory Panel (RP), Blood Culture Identification (BCID) Panel, and Gastrointestinal (GI) Panel). Each panel was evaluated in three studies, a clinical specimen comparison study, a low analyte study, and a reproducibility study. The clinical comparison study involved testing a set of clinical samples using both the current FilmArray 2.0. The low analyte study compared the performance of the two devices by testing contrived samples spiked around the previously-determined limit of detection (LoD) for each assay on the panel. The reproducibility study was conducted using multi-instrument FilmArray 2.0 systems and involved testing of a set of well-characterized contrived samples at three different testing sites over several days and comparing the results to those previously obtained with the current FilmArray device. In all studies (i.e., detection in clinical specimens, detection of low analyte levels, and reproducibility) the performance of all three panels was found to be equivalent on the previously cleared FilmArray and the FilmArray 2.0. Data generated in these studies are presented in three concurrently-submitted 510(k) premarket notifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked one in front of the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOFIRE DIAGNOSTICS, LLC KRISTEN KANACK, Ph.D. VICE PRESIDENT OF REGULATED PRODUCTS 390 WAKARA WAY SALT LAKE CITY UT 84108
January 30, 2015
Re: K143178
Trade/Device Name: FilmArrav 2.0 Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: II Product Code: NSU Dated: October 31, 2014 Received: November 4, 2014
Dear Dr. Kanack:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143178
Device Name FilmArray 2.0
Indications for Use (Describe)
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The software automatically determines the results and provides a test report.
The FilmArray 2.0 is composed of one to eight instruments connected to a computer running FilmArray 2.0 software, which controls the function of each instrument and collects, and stores data generated by each instrument.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary BioFire Diagnostics, LLC
FilmArrav® 2.0
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitted by:
BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108
Telephone: 801-736-6354 Facsimile: 801-588-0507
Contact: Kristen Kanack, ext. 330
Date Submitted: October 31, 2014
Device Name and Classification:
Trade Name: FilmArray 2.0
Regulation Number: 21 CFR 862.2570
Classification Name: Instrumentation for clinical multiplex test systems
Predicate Device:
K103175 – FilmArray
Intended Use:
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The software automatically determines the results and provides a test report.
The FilmArray 2.0 is composed of one to eight instruments connected to a computer running FilmArray 2.0 software, which controls the function of each instrument and collects, analyzes, and stores data generated by each instrument.
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Device Description:
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed to work with specific FilmArray reagent panels to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with a reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray 2.0 software automatically determines the results and provides a test report.
The FilmArray 2.0 permits up to eight instruments to connect to one computer. This configuration reduces the space requirements for the system and offers centralized data management. Accessories for the FilmArray 2.0 include a computer stand and printer, a barcode scanner, an external Ethernet switch that allows several instruments to connect to a single computer, and an optional modular rack system to stack two instruments.
The main functions of the FilmArray 2.0 are as follows:
- Moving liquids within the pouch and delivering rehydrated reagents in a specified . sequence to drive the nucleic acid purification and PCR amplification reactions.
- . Heating and cooling to drive the PCR reactions and DNA melting.
- . Capturing and processing of fluorescence images for analysis by the software.
- . Automated data interpretation and test report generation.
Principles of Operation:
A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and a patient sample mixed with the provided Sample Buffer into the other port of a FilmArray pouch and placing it in the FilmArray instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.
The FilmArray 2.0 instrument contains a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister. it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.
Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical Iysis followed by purification using standard magnetic bead technology. The instrument has a built-in
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bead-beater to aid in mechanical lysis and a retractable magnet that is used to capture the magnetic beads used in the nucleic acid purification process. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. During the first stage, a single, large volume, highly-multiplexed PCR reaction is performed (including reverse transcription of RNA to DNA, when needed). The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye (LC Green® Plus, BioFire Defense). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 200 stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.
The software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the reagent panel.
Substantial Equivalence:
The FilmArray 2.0 is substantially equivalent to the current FilmArray device. The current FilmArray was cleared as a system with the FilmArray Respiratory Panel on February 17, 2011 under 510(k) K103175 and was determined to be a Class II device.
The following tables compare the FilmArray 2.0 to the current FilmArray device. Table 1 outlines the similarities and differences between the two devices.
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| Element | Predicate:
FilmArray (K103175) | New Device:
FilmArrav 2.0 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The FilmArray instrument is an automated
in vitro diagnostic (IVD) device designed
to work with specific reagent pouches to
detect multiple nucleic acid targets
contained in clinical specimens. The
instrument interacts with the reagent
pouch to both purify nucleic acids and
amplify targeted nucleic acid sequences
using nested multiplex PCR in a closed
system. The resulting PCR products are
evaluated using DNA melting analysis.
The FilmArray software then
automatically interprets the results and
provides an easy-to-understand test report.
The FilmArray device is composed of the
FilmArray instrument and a laptop
computer loaded with FilmArray software.
The instrument contains a series of
pneumatic actuators that move liquid
within the pouch, a bead beater for
disrupting the specimen during nucleic
acid purification, two Peltier devices to
drive thermocycling and DNA melting,
and an optics system for detecting
fluorescent signals. The FilmArray
software controls the function of the
instrument and collects, stores, and
analyzes data generated by the instrument. | Same |
| Assays | For use with FDA cleared FilmArray
panels:
Respiratory Panel (RP)
Blood Culture Identification (BCID) Panel
Gastrointestinal (GI) Panel | Same |
| Protocol
Processing Steps | Cell disruption, nucleic acid extraction,
PCR1 thermocycling, PCR2
thermocycling, DNA melt and signal
detection. | Same |
| Time to result | Approximately 1 hour per sample | Same |
| Technological
Principles | Nested multiplex nucleic acid
amplification (including reverse
transcription as appropriate) followed by
high-resolution melting analysis to
confirm the identity of the amplified
product. | Same |
| Element | Predicate:
FilmArray (K103175) | New Device:
FilmArray 2.0 |
| Required
Accessory | FilmArray reagent pouch | Same |
| Sample
Preparation
Method | Minimal sample processing and hands-on
time. | Same |
| Test Interpretation
and Results
Reporting | Automated test interpretation and report
generation. User cannot access raw data.
Report can be printed. | Same |
| User Complexity | Moderate | Same |
| Instrument Optics | Charge-coupled device (CCD) camera. | Complimentary metal-oxide
semiconductor (CMOS) camera |
| | Soft-coated filters. | Hard-coated filters. |
| Instrument -
Software
Communication | Communication travels via Firewire and
USB cables/ports. | Communication travels via Ethernet
cable/port.
Communication for multiple instruments
mediated by a multi-port switch. |
| Device
configuration | One FilmArray instrument to one laptop
computer with mouse, barcode scanner
and pouch loading station.
Single-sample test capacity. | Up to eight FilmArray 2.0 instruments to
one computer with mouse, barcode scanner
and pouch loading station.
Single-sample test capacity per instrument
with random-access multi-sample test
capacity per system. |
| | Printer optional. | Printer provided with the system. |
| | Instrument held at 0° angle. | Interlocking two-instrument racks
available to stack instruments and reduce
system footprint. (Optional)
Instrument held at 0° angle when no rack
is used. Instrument held at 15° angle on
rack. |
Table 1. Comparison between FilmArray 2.0 and the Current FilmArray Device.
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Summary of Performance Data:
The performance of the FilmArray 2.0 was evaluated using three FDA cleared FilmArray Panels (Respiratory Panel (RP), Blood Culture Identification (BCID) Panel, and Gastrointestinal (GI) Panel). Each panel was evaluated in three studies, a clinical specimen comparison study, a low analyte study, and a reproducibility study. The clinical comparison study involved testing a set
8
of clinical samples using both the current FilmArray 2.0. The low analyte study compared the performance of the two devices by testing contrived samples spiked around the previously-determined limit of detection (LoD) for each assay on the panel. The reproducibility study was conducted using multi-instrument FilmArray 2.0 systems and involved testing of a set of well-characterized contrived samples at three different testing sites over several days and comparing the results to those previously obtained with the current FilmArray device. In all studies (i.e., detection in clinical specimens, detection of low analyte levels, and reproducibility) the performance of all three panels was found to be equivalent on the previously cleared FilmArray and the FilmArray 2.0. Data generated in these studies are presented in three concurrently-submitted 510(k) premarket notifications.